Pain, Postoperative
Conditions
Keywords
Acetaminophen, Pain, Postoperative, Analgesia, Obstetrical, Cesarean Section
Brief summary
This study will compare IV (intravenous) versus oral (PO) acetaminophen for postoperative pain after scheduled, elective Cesarean delivery. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three doses, (group 2) 1 gram oral acetaminophen every 8 hours for three doses, or (group 3) no acetaminophen. This will be a randomized, open label study.
Detailed description
This study will compare IV versus PO acetaminophen for postoperative pain in parturients after scheduled, elective Cesarean delivery. It is designed as a randomized, open label, controlled trial. All patients will receive a standardized spinal anesthetic for operative anesthesia and will be randomized into one of three groups: (group 1) 1 gram IV acetaminophen every 8 hours for three by a computer generated list.
Interventions
DRUGAcetaminophen Intravenous
IV 1 gram f3 doses over 24 hours
Oral 1 gram 3 doses over 24 hours
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Parturients 18 years * Elective Cesarean delivery * Spinal anesthesia * Able to consent to the study and participate in the follow-up.
Exclusion criteria
* Weight under 50 kgs * Allergy to acetaminophen * General anesthesia * Urgent or emergent cases * Bleeding diathesis or other coagulopathy * G6PD deficiency * Liver disease * Substance abuse or dependence * HELLP syndrome * Thrombocytopenia or platelet dysfunction * History or active gastrointestinal bleeding * Acute kidney injury or chronic renal insufficiency * Contraindication/refusal to spinal anesthesia * Chronic pain * Chronic narcotic use * Illicit drug use * Allergy to any study related medications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative Postoperative Opiate Consumption | 24 hours | Cumulative opiate consumption (IV morphine equivalents) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Opiate Rescue | 48 hours | Time to first opiate pain medicine requested by patient |
| VAS (Visual Analog Scale) | 24 hours | Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 \[100-mm scale\]) . |
| Time Discharge | 24 hours postoperative | Time patient meets discharge criteria will be recorded |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Acetaminophen Intravenous (group 1) 1 gram IV acetaminophen every 8 hours for three doses
Acetaminophen Intravenous: IV 1 gram f3 doses over 24 hours | 47 |
| Acetaminophen Oral (group 2) 1 gram oral acetaminophen every 8 hours for three doses
Acetaminophen Oral: Oral 1 gram 3 doses over 24 hours | 47 |
| No Acetaminophen (group 3) no acetaminophen | 47 |
| Total | 141 |
Baseline characteristics
| Characteristic | Acetaminophen Oral | No Acetaminophen | Total | Acetaminophen Intravenous |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 47 Participants | 141 Participants | 47 Participants |
| Age, Continuous | 30.5 years | 31.2 years | 30.1 years | 28.7 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 21 Participants | 57 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 32 Participants | 26 Participants | 82 Participants | 24 Participants |
| Region of Enrollment United States | 47 participants | 47 participants | 141 participants | 47 participants |
| Sex: Female, Male Female | 47 Participants | 47 Participants | 141 Participants | 47 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 47 | 0 / 47 |
| other Total, other adverse events | 0 / 47 | 0 / 47 | 0 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 | 0 / 47 |
Outcome results
Primary
Cumulative Postoperative Opiate Consumption
Cumulative opiate consumption (IV morphine equivalents)
Time frame: 24 hours
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Acetaminophen Intravenous | Cumulative Postoperative Opiate Consumption | 2.9 mg |
| Acetaminophen Oral | Cumulative Postoperative Opiate Consumption | 3.8 mg |
| No Acetaminophen | Cumulative Postoperative Opiate Consumption | 5.7 mg |
Secondary
Time Discharge
Time patient meets discharge criteria will be recorded
Time frame: 24 hours postoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen Intravenous | Time Discharge | 48.4 hours | Standard Deviation 13.7 |
| Acetaminophen Oral | Time Discharge | 48.6 hours | Standard Deviation 11.3 |
| No Acetaminophen | Time Discharge | 50.5 hours | Standard Deviation 15.7 |
Secondary
Time to First Opiate Rescue
Time to first opiate pain medicine requested by patient
Time frame: 48 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen Intravenous | Time to First Opiate Rescue | 25.3 hours | Standard Error 8.5 |
| Acetaminophen Oral | Time to First Opiate Rescue | 24.0 hours | Standard Error 26.3 |
| No Acetaminophen | Time to First Opiate Rescue | 21.3 hours | Standard Error 23.9 |
Secondary
VAS (Visual Analog Scale)
Visual Analog Scale (VAS) pain assessment with ambulation. The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain and worst pain. For pain intensity, the scale is most commonly anchored by no pain (score of 0) and pain as bad as it could be or worst imaginable pain (score of 100 \[100-mm scale\]) .
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acetaminophen Intravenous | VAS (Visual Analog Scale) | 37.8 units on a scale | Standard Error 3.23 |
| Acetaminophen Oral | VAS (Visual Analog Scale) | 44.3 units on a scale | Standard Error 3.28 |
| No Acetaminophen | VAS (Visual Analog Scale) | 50.8 units on a scale | Standard Error 3.31 |